Trial Outcomes & Findings for Diabetes Care for Breast Cancer Patients (NCT NCT05565534)
NCT ID: NCT05565534
Last Updated: 2026-07-08
Results Overview
Number of participants recruited divided by the number of participants approached
COMPLETED
NA
74 participants
2 years
2026-07-08
Participant Flow
Each week, our study team reviewed multi-disciplinary tumor board lists to identify potential participants. Upon identifying these individuals, every Friday morning we sent the list of patients to the breast medical oncology team for review and approval. By the end of the day on Friday, we received an approved list of patients that we could approach for the study. Our team would then either call the patient by phone or approach them at their next medical oncology appointment.
Participant milestones
| Measure |
Nurse-practitioner Led Intervention Group
A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Nurse-practitioner Led Intervention Group
A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Overall Study
Screening Failure
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Did not initiate study procedures
|
0
|
5
|
Baseline Characteristics
1 participant assigned to the intervention group chose not to disclose their marital status.
Baseline characteristics by cohort
| Measure |
Nurse-practitioner Led Intervention Group
n=36 Participants
A nurse practitioner (NP) who is trained in diabetes on the oncology team will help manage diabetes for breast cancer patients undergoing cancer treatments
|
Non-intervention (Control) Group
n=33 Participants
Patient will not have access to the nurse practitioner led intervention.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Marital Status
Married/Domestic Partnership
|
9 Participants
n=35 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
15 Participants
n=33 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
24 Participants
n=68 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
|
Marital Status
Widowed/Divorced/Separated
|
16 Participants
n=35 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
14 Participants
n=33 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
30 Participants
n=68 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
|
Age, Continuous
|
65.257 Years
STANDARD_DEVIATION 10.322 • n=35 Participants • One participant assigned to the intervention group declined to give their age.
|
64.424 Years
STANDARD_DEVIATION 16.739 • n=33 Participants • One participant assigned to the intervention group declined to give their age.
|
64.853 Years
STANDARD_DEVIATION 13.714 • n=68 Participants • One participant assigned to the intervention group declined to give their age.
|
|
Sex: Female, Male
Female
|
34 Participants
n=36 Participants
|
32 Participants
n=33 Participants
|
66 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=36 Participants
|
1 Participants
n=33 Participants
|
3 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
11 Participants
n=36 Participants
|
7 Participants
n=33 Participants
|
18 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
|
17 Participants
n=36 Participants
|
14 Participants
n=33 Participants
|
31 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Asian
|
2 Participants
n=36 Participants
|
6 Participants
n=33 Participants
|
8 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latinx
|
6 Participants
n=36 Participants
|
4 Participants
n=33 Participants
|
10 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other/Multiple Races
|
0 Participants
n=36 Participants
|
2 Participants
n=33 Participants
|
2 Participants
n=69 Participants
|
|
Marital Status
Single
|
10 Participants
n=35 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
4 Participants
n=33 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
14 Participants
n=68 Participants • 1 participant assigned to the intervention group chose not to disclose their marital status.
|
|
Educational Attainment
High school degree or less
|
7 Participants
n=36 Participants
|
9 Participants
n=33 Participants
|
16 Participants
n=69 Participants
|
|
Educational Attainment
Some college
|
8 Participants
n=36 Participants
|
8 Participants
n=33 Participants
|
16 Participants
n=69 Participants
|
|
Educational Attainment
College degree
|
15 Participants
n=36 Participants
|
7 Participants
n=33 Participants
|
22 Participants
n=69 Participants
|
|
Educational Attainment
Graduate degree
|
6 Participants
n=36 Participants
|
9 Participants
n=33 Participants
|
15 Participants
n=69 Participants
|
|
Health Insurance (Private/Public)
Private
|
13 Participants
n=36 Participants
|
10 Participants
n=33 Participants
|
23 Participants
n=69 Participants
|
|
Health Insurance (Private/Public)
Medicare
|
16 Participants
n=36 Participants
|
14 Participants
n=33 Participants
|
30 Participants
n=69 Participants
|
|
Health Insurance (Private/Public)
Medicaid
|
4 Participants
n=36 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=69 Participants
|
|
Health Insurance (Private/Public)
Medicare & Medicaid
|
3 Participants
n=36 Participants
|
3 Participants
n=33 Participants
|
6 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of participants recruited divided by the number of participants approached
Outcome measures
| Measure |
Total Approached Participants
n=127 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Recruitment Success Ratio
|
0.54 patient recruited per patient approached
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Per protocol, all participants in the intervention group who were enrolled were analyzed for this measure.
(Intervention only) Number of participants who completed the intervention divided by the number of participants who were enrolled.
Outcome measures
| Measure |
Total Approached Participants
n=36 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Intervention Completion Ratio
|
0.89 pt. completed per pt. enrolled
|
—
|
PRIMARY outcome
Timeframe: 2 yearsNumber of participants who completed both surveys divided by the number of participants who were enrolled.
Outcome measures
| Measure |
Total Approached Participants
n=36 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=38 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Data Collection Success Ratio
|
0.89 completed pts per enrolled pt
|
0.84 completed pts per enrolled pt
|
PRIMARY outcome
Timeframe: Immediately post-intervention at the week ~12 follow-upPopulation: Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure.
Questionnaire: Feasibility of Intervention Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating that the intervention is very feasible, and lower scores (below 3) indicating the intervention is not feasible.
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Patient Questionnaire: Self-report of Intervention Feasibility
This NP-led intervention for co-managing (pre)diabetes and breast cancer seems implementable.
|
4.16 score on a scale
Standard Deviation 0.72 • Interval 2.0 to 5.0
|
—
|
|
Patient Questionnaire: Self-report of Intervention Feasibility
This NP-led intervention for co-managing diabetes/pre-diabetes and breast cancer seems possible.
|
4.28 score on a scale
Standard Deviation 0.73
|
—
|
|
Patient Questionnaire: Self-report of Intervention Feasibility
This NP-led intervention for co-managing diabetes/pre-diabetes and breast cancer seems doable.
|
4.16 score on a scale
Standard Deviation 0.73
|
—
|
|
Patient Questionnaire: Self-report of Intervention Feasibility
This NP-led intervention for co-managing (pre)diabetes and breast cancer seems easy to carry out.
|
4.03 score on a scale
Standard Deviation 0.86
|
—
|
PRIMARY outcome
Timeframe: Immediately post-intervention at the week 12 follow-upPopulation: Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure.
Questionnaire: Acceptability of Intervention Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating more favorable attitudes toward the intervention and lower scores (below 3) indicating less favorable attitudes.
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Patient Questionnaire: Self-report of Intervention Acceptability
This NP-led intervention is appealing to me.
|
4.09 score on a scale
Standard Deviation 0.86
|
—
|
|
Patient Questionnaire: Self-report of Intervention Acceptability
This NP-led intervention to co-manage my diabetes/pre-diabetes and chemotherapy meets my approval.
|
4.16 score on a scale
Standard Deviation 0.69
|
—
|
|
Patient Questionnaire: Self-report of Intervention Acceptability
I like this NP-led intervention.
|
4.10 score on a scale
Standard Deviation 0.79
|
—
|
|
Patient Questionnaire: Self-report of Intervention Acceptability
I welcome this NP-led intervention to co-manage my diabetes/pre-diabetes and chemotherapy.
|
4.19 score on a scale
Standard Deviation 0.74
|
—
|
PRIMARY outcome
Timeframe: Immediately post-intervention at the week 12 follow-upPopulation: Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure.
Questionnaire: Intervention Appropriateness Measure (4 items) Response Scale: For each item, respondents can choose a value from 1-5. Scales can be created for the measure by averaging responses for all 4 items for the overall score. The average score range is from 1 to 5 with higher scores indicating the intervention suits their needs well and lower scores (below 3) indicating the intervention does not fit their needs well.
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Patient Questionnaire: Self-report of Intervention Appropriateness
This NP-led intervention seems fitting for co-managing my diabetes/pre-diabetes and chemotherapy.
|
4.00 score on a scale
Standard Deviation 0.95
|
—
|
|
Patient Questionnaire: Self-report of Intervention Appropriateness
This NP-led intervention seems suitable for co-managing my diabetes/pre-diabetes and chemotherapy.
|
4.06 score on a scale
Standard Deviation 0.95
|
—
|
|
Patient Questionnaire: Self-report of Intervention Appropriateness
This NP-led intervention seems applicable for co-managing my diabetes/pre-diabetes and chemotherapy.
|
3.97 score on a scale
Standard Deviation 0.93
|
—
|
|
Patient Questionnaire: Self-report of Intervention Appropriateness
This NP-led intervention seems like a good match for co-managing my (pre)diabetes and chemotherapy.
|
4.09 score on a scale
Standard Deviation 0.96
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure.
Number of patients who had a summary document created for them compared to the number of patients who complete the follow-up visit.
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Ratio of Patients Who Had a Summary Document Created for Them at the End of the Intervention
|
1.00 summary docs to f/u surveys
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Per protocol, only participants in the intervention group who also completed the baseline survey were analyzed for this measure.
This will assess the degree to which the intervention was implemented over the course of the study
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Mean Number of In-person, Virtual or Phone Contacts With the NP Per Participant.
|
6.38 contacts per patient
Standard Deviation 2.21 • Interval 4.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: From baseline to week 12 follow-up visitPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Diabetes Treatment Satisfaction Questionnaire (8 items) DTSQ, score 0-36; higher scores reflecting higher satisfaction
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
Diabetes Treatment Satisfaction Score - Follow-Up
|
33.000 score on a scale
Standard Deviation 7.204
|
32.250 score on a scale
Standard Deviation 7.430
|
|
Change in Patient Self-report Responses of Diabetes Treatment Satisfaction Questionnaire
Diabetes Treatment Satisfaction Score - Baseline
|
29.700 score on a scale
Standard Deviation 6.320 • Interval 0.0 to 2.0
|
31.286 score on a scale
Standard Deviation 9.369 • Interval -3.0 to 4.0
|
SECONDARY outcome
Timeframe: At week 12 follow-up visitPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Neuropathy - PRO-CTCAE (2 items) 0-8 with higher scores representing worse neuropathy
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Severity of Patient Self-report Responses of Neuropathy as Measured By the PRO-CTCAE Survey at Follow-up
|
1.562 score on a scale
Standard Deviation 1.900
|
1.969 score on a scale
Standard Deviation 2.024
|
SECONDARY outcome
Timeframe: From baseline to Week 12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Diabetes Distress Scale (17 items) A score of "1" indicates a particular item is not a problem or bother for the patient, whereas "6" represents an item is very concerning for the patient. To score, the patient's responses will be summed and then divided by the number of items in that scale. A mean score of 3 or higher (moderate distress) is considered as a level of distress that is above average. (decrease in score means the item is considered less of a problem/bother)
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
Total DDS Score - Baseline
|
1.624 score on a scale
Standard Deviation 0.757
|
1.573 score on a scale
Standard Deviation 0.721
|
|
Change in Patient Self-report Responses of Diabetes Distress Scale Questionnaire
Total DDS Score - Follow-Up
|
1.563 score on a scale
Standard Deviation 0.789
|
1.549 score on a scale
Standard Deviation 0.627
|
SECONDARY outcome
Timeframe: From baseline to Week 12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Functional Assessment of Cancer Therapy -Breast (44-items) measures quality of life for patients with breast cancer. Total scores range from 0-148 with higher scores representing better quality of life.
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire
Fact-B Total Score - Baseline
|
101.655 score on a scale
Standard Deviation 23.116
|
99.755 score on a scale
Standard Deviation 25.594
|
|
Change in Patient Self-report Responses of the Functional Assessment of Cancer Therapy-Breast Questionnaire
Fact-B Total Score - Follow-Up
|
98.109 score on a scale
Standard Deviation 26.960
|
98.393 score on a scale
Standard Deviation 25.529
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
The average number of hospitalizations since study enrollment
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Average Number of Hospitalizations Since Study Enrollment
|
0.323 hospitalizations
Standard Deviation 0.653
|
0.125 hospitalizations
Standard Deviation 0.421
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
The average number of emergency department (ED) visits since study enrollment
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Average Number of ED Visits Since Study Enrollment
|
0.562 ED visits
Standard Deviation 0.759
|
0.344 ED visits
Standard Deviation 0.701
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Average number of planned chemo sessions that were not completed by participants
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Average Number of Uncompleted Chemotherapy Sessions
|
0.812 Uncompleted Chemo sessions
Standard Deviation 1.693
|
1.969 Uncompleted Chemo sessions
Standard Deviation 3.487
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
The proportion of planned chemo session completed during study enrollment, as a percentage
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Proportion of Planned Chemo Session Completed (%)
|
82.895 % of planned chemo sessions completed
Standard Deviation 24.957
|
74.372 % of planned chemo sessions completed
Standard Deviation 27.513
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Whether or not participants had their chemotherapy dose reduced
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Chemo Dose Reduction
Yes, did have dose reduced
|
6 participants
|
7 participants
|
|
Chemo Dose Reduction
No, did not have dose reduced
|
26 participants
|
25 participants
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Average last HbA1c level
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Most Recent HbA1c Level
|
6.727 HbA1c
Standard Deviation 1.113
|
7.265 HbA1c
Standard Deviation 2.368
|
SECONDARY outcome
Timeframe: From baseline to Week ~12 follow-upPopulation: Per protocol, only participants who completed both the baseline survey and the follow-up survey were analyzed for this measure.
Average highest glucose measure during treatment
Outcome measures
| Measure |
Total Approached Participants
n=32 Participants
Total number of individuals approached
|
Non-intervention (Control) Group
n=32 Participants
Patient will not have access to the nurse practitioner led intervention.
|
|---|---|---|
|
Highest Glucose During Treatment
|
207.700 mg/dL
Standard Deviation 89.161
|
242.897 mg/dL
Standard Deviation 188.603
|
Adverse Events
Nurse-practitioner Led Intervention Group
Non-intervention (Control) Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place